Novartis Remibrutinib Meets Phase III Primary Endpoint in Chronic Inducible Urticaria

Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU). The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria and cholinergic urticaria, achieving significantly higher complete response rates versus placebo at Week 12.

These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need. The Global Head of Immunology Development stated that the positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU). The findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions.

Remibrutinib was well-tolerated and demonstrated a favorable safety profile, including no liver safety concerns. The drug is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives (wheals) and swelling. By reducing histamine release, remibrutinib helps relieve the symptoms of CIndU.

Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of CIndU. In the coming months, the full data set will be submitted to health authorities globally, and the RemIND trial findings will be presented in upcoming medical congresses.

The RemIND trial (NCT05976243) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of remibrutinib in adults with CIndU inadequately controlled by H1-antihistamines. The primary endpoint of RemIND is the proportion of complete responders at Week 12 assessed through provocation tests specific to three CIndU subtypes.

Chronic inducible urticaria is a chronic skin condition affecting an estimated 0.5 percent of the population or 29 million people worldwide. It is a form of chronic urticaria characterized by hives and/or swelling, with identifiable external triggers, like pressure, sunlight, friction, heat, cold or water. CIndU differs from chronic spontaneous urticaria (CSU), which has no specific triggers. CIndU places a significant burden on daily life, with many patients cycling through antihistamines without adequate relief. With no approved targeted therapies available today, there remains a clear and longstanding gap in effective treatment options for these patients.

The most prevalent CIndU subtypes are symptomatic dermographism, cold urticaria, and cholinergic urticaria. Symptomatic dermographism manifests with itchy hives caused by shear force on skin, such as friction or light scratching, which appear in less than 5 minutes after contact and usually last 30 minutes. Cold urticaria occurs after skin exposure to cold, leading to wheals or angioedema that develop within minutes after exposure and are usually limited to exposed areas. Cholinergic urticaria manifests with characteristic small, punctate hives triggered by active or passive heating of the body, including exercise, strong emotions, or bathing in hot water.

In the US and China, remibrutinib is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines, under the brand name Rhapsido. Remibrutinib is being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company's Neuroscience portfolio.